I was struck in reading (at 3:25 AM) the FDA’s update of the Cyclospora outbreak that has sickened nearly 650 in 22 states this summer, that we still do not know exactly how the outbreak happened and the source of all, or most of the illnesses. Although “[e]pidemiologic and traceback investigations by the states of Iowa and Nebraska, the CDC and the FDA had linked salad mix supplied by [Taylor Farms de Mexico, S. de R.L. de C.V.,] to Olive Garden and Red Lobster restaurants, which are owned by Darden Restaurants,” those account for only 242 of the illnesses. Texas, which has nearly 300 of the illnesses, has not linked those illnesses to the same source – neither have the other 19 states. As the CDC said, “[t]he preliminary analysis of results from an investigation into a cluster of cases that ate at a Texas restaurant does not show a connection to Taylor Farms de Mexico. This investigation is ongoing.”

It does beg the question (well, actually several), if Taylor Farms de Mexico, S. de R.L. de C.V., is not the source of nearly 400 of the illnesses, what is? Assuming that health officials in Iowa and Nebraska and at the CDC and FDA are correct on the source of the illnesses in those states, what accounts for illnesses that run from at least June 1 to August 6 in all the other states? It is hard to imagine salad mix lasting that long – because it would not. Is there some component of the salad mix with a longer shelf life that is the common denominator? Or, given the long Epi Curve, is there an environmental part of this outbreak that has sustained the illnesses in other products grown in the same region of Mexico?

The FDA update raises other questions as well. Over a month and a half after the first reported illness, “[f]rom August 11-19, 2013, the FDA with the cooperation of Mexican government authorities and Taylor Farms de Mexico, S. de R.L. de C.V., conducted a thorough environmental assessment at Taylor Farms de Mexico’s processing facility and five farms identified through the Cyclospora outbreak’s traceback investigation.” Not surprisingly, “[t]he team found that conditions and practices observed at these facilities at the time of the assessment were in accordance with known food safety protocols.” As the FDA pointed out, the likely reason that things looked good at Taylor Farms was because “[t]he last date that someone who had eaten in one of these restaurants in those states reportedly became ill with cycloporiasis was on July 2, more than five weeks prior to start of the Environmental Assessment.”

Based upon the FDA’s review, “Taylor Farms de Mexico, S. de R.L. de C.V., resumed production and shipment of salad mix, leafy greens, and salad mix components from its operations in Mexico to the United States.” It appears that the FDA’s decision was based in part on “the recent environmental assessment [AND] FDA’s thorough review of a product sampling plan for Cyclospora put in place by Taylor Farms de Mexico, S. de R.L. de C.V.”

It does beg the question, what if any Cyclospora sampling plan did Taylor Farms have before the FDA arrived and before the outbreak that they have in part been linked to?

Clearly, more questions than answers, and, although I have been retained by dozens of ill, it is why I have held off in the lawsuit filling frenzy that we have seen. It is more important to get it right than be first. That is as true in lawsuits as it is in Epi surveillance.